The present invention relates to an improved system for collecting body fluids and unique components of the system. In particular, the system also includes a unique latching mechanism, vented valve, sound muffler, collection bottle, control mechanism, and pump and motor suspension system.
Urinary incontinence in patients, whether in hospitals, nursing homes, or at home, and irrespective of whether they are restricted to a wheelchair or bed or are ambulatory, presents a particular and continuing problem with respect to the care of such patients. Such incontinence is even more prevalent among the elderly. The problem is prevalent in both male and female patients but, for anatomical reasons, incontinence is a particular problem for women.
Methods used to manage these problems include frequent change of bedding, use of absorbent padding under the patients buttocks, perineal pads of various designs, or diapers. In order for these measures to be effective, the patient must be checked frequently and the moist padding must be changed promptly when damp. Diabetes Mellitus is a common ailment among these patients; the medical management of such patients may require checking tests of the urine several times daily. The use of pads and diapers impedes the collection of the necessary urine specimens for such testing. Such pads and diapers normally involve an absorbent core, typically a cellulose wadding or other hydroscopic material. These substances can absorb fluid only at a limited rate, and their total absorptive capacity is a function of their mass, typically about 10 grams of fluid per gram of material. Thus, the pad or diaper must be bulky in order to have an adequate capacity. Some pads and diapers incorporate hydroscopic gels to increase their absorptive capacity and minimize "wet-back", the release of previously absorbed fluid. As the gel absorbs fluid, it may form a barrier preventing penetration of fluid to more distal absorptive material. All pads and diapers have a limited and finite absorbency. Whenever the rate and volume of fluid passed exceeds this absorptive capacity, the excess leaks onto the clothing and bedding. Thus, such pads and diapers must be monitored frequently, replaced as soon as they become moist and before their capacity has been exceeded. Such monitoring must be carried out day and night at considerable inconvenience and expense.
Bacterial breakdown of urine within the moist padding may result in the release of ammonia which leads to skin irritation. Further bacterial activity may lead to skin breakdown and frank ulceration. Furthermore, bacterial multiplication within moist pads, diapers, clothing or bedding often produces noxious odors, unpleasant to patient, family members and care givers alike. Wet clothing and bedding must also be changed and this adds significantly to the time and expense associated with the care of incontinent patients. Added to the physical problems associated with the wet pads, diapers, clothing and bedding is the psychological and emotional cost to the patient and patient's family of the patient's regression to the child-like state of wearing pads or diapers. Replacement of urine soaked bulky pads and diapers involves handling pads and diapers, which is an unpleasant task, and which presents a risk of infection to the care giver. Changing of wet clothing and wet bedding also requires, generally, the services of more than one care giver with an attendant rise in the cost of providing care. Further, repeated replacement is also associated with the inconvenience and cost of storing a large number of pads, diapers, clothing and bedding to be ready for use and the costs associated with disposing of the pads and diapers and the added cost of cleaning the clothing and bedding. The disposal of large numbers of bulky, urine soaked pads and diapers creates an environmental and sanitary disposal problem of increasing concern.
Earlier attempts at dealing with the urinary incontinence problem include U.S. Pat. Nos. 3,349,768; 4,610,675; 4,713,065; 4,200,102; and 4,886,508. Foreign patents dealing with urinary incontinence include U.K. Patent No. 2,148,126A and French Patent No. 1,485,683.
A more recent method of dealing with urinary incontinence is disclosed in U.S. Pat. No. 4,747,166 to David H. Kuntz, entitled "Fluid Aspiration System for the Management of Urinary Incontinence." The aspiration system disclosed therein includes a vacuum pump and urine collection reservoir connected via a tube to an absorbent pad. The tube is connectable to the pad in one case through an opening and in another case by an opening engaging a coupling adapter. The pad disclosed therein had a series of highly absorbent cellulose tissue layers. The tissue layers are surrounded at the bottom by a thin impermeable layer and at the top by a permeable layer, the two layers joined at the lateral edges of the pad. In the preferred embodiment, a vacuum source connected to the system operates continuously, not only aspirating urine absorbed by the pad but, continuously, drawing air through the patient-pad interface, thus drying the pad and the contiguous skin surface. The Kuntz patent also discloses an embodiment which incorporates a fluid sensor in the pad which acts to turn off the pump if no fluid is present.
A similar approach was disclosed by Frank D. Martin in U.S. Pat. No. 4,631,061. The Martin aspiration system includes a vacuum pump and urine collection reservoir connected via a tube to a collection vessel formed from a non-absorbent, liquid impervious material. The Martin collection vessel or tube further includes a sensor which detects the presence of urine. The sensor is connected to the pump on-off switch so the vacuum pump is automatically turned off if no urine is present.
It has been found that devices such as shown in Kuntz or Martin have several deficiencies regarding the ease of operation, the procedures for connecting and emptying the collection container and techniques for removing a fresh urine sample without opening the system. Further, it has been demonstrated that urine will travel posteriorly in or on a collection pad or vessel in a supine or reclining patient and that sensors in the outflow of the pad or collection means may be bypassed with the result that the patient, the patient's clothing and the patient's bedding may become wet. Additionally, the time delay in establishing the level of vacuum required to aspirate the urine from the collection means may be significant if the vacuum pump is in the off mode noted in the Kuntz and Martin devices. Such systems where urine is aspirated through tubing into a reservoir connected to a vacuum pump present certain design problems: For example, emptying such a reservoir at a reasonable rate requires special design of the drainage port to permit rapid inflow of air to offset pump action. Means must be incorporated to prevent accidental backflow of urine from the reservoir to the pad or collection vessel. Aspiration of fluid from the reservoir into the pump, thereby damaging or disabling it, must be prevented. Since the reservoir may contain infected urine, some means must be provided to prevent discharge into the room of hazardous fluids by aerosolization. The mechanism must be protected from damage due to tipping or overfilling of the reservoir. As urine aspiration requires a constant source of vacuum, means to indicate kinked tubing or other blockage of the system preventing flow should be provided. In the event of any of these occurrences, means to alert the patient or care giver should be provided. Parts of the system more likely to require servicing or replacement, (for example, the tubing, filers or reservoir) must be designed so that servicing or replacement may be done with ease. The system should contain means for securing a fresh sample of urine for monitoring diabetes. It must include means for operation when the patient is out of bed, in a wheel chair, or is ambulatory. This type of operation obviously must be by battery; so, means must be included to indicate the type of power in use, and the status of the battery. Since battery life is generally proportional to battery size and weight, the design must incorporate sufficient power without requiring overly frequent recharging. These means include a pump with low current draw and an integral battery recharging system. Since passage of urine is an intermittent function, means should be provided to modify pump performance to the changing requirements of the system.
All of these requirements should be provided by a device which is sturdy, yet small and light enough to be carried in one hand and easily adaptable to be attached to a bed or wheel chair. The controls and indicators must be sufficiently simple so the system may be safely and efficiently operated by relatively unsophisticated persons.
Thus, there is a need for a fluid collection device capable of continuous operation for collecting urine from incontinent patients that is safe to use, easy to operate, convenient to set up or empty, allows easy replacement of disposable elements such as tubing and the urine collection reservoir, has a minimized risk of spilling, overflowing or otherwise contaminating the vacuum pump or surrounding area, and offers the ability to obtain fresh urine samples without disconnection the system, removing the collection pad or shutting off the pump.